February 5, 2010

January 2010 510(k) Clearances

Solo Micro Pump, Finesse Insulin Deliver Patch, Nova Max BG and Ketone Meter, more...

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm199999.htm
DEVICE: SOLO MICROPUMP INSULIN DELIVERY SYSTEM
MEDINGO LTD. 510(k) NO: K093364(TRADITIONAL)
ATTN: ARAVA HACOHEN PHONE NO : 972 737 131313
YOQNEAM INDUSTRIAL PARK BLDG.7 3RDSE DECISION MADE: 25-JAN-10
YOQNEAM IS 20692 510(k) SUMMARY AVAILABLE FROM FDA
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093364.pdf


DEVICE: FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
CALIBRA MEDICAL, INC. 510(k) NO: K093065(TRADITIONAL)
ATTN: RICHARD J MEADER PHONE NO : 650 298 4740
220 SAGINAW DRIVE SE DECISION MADE: 20-JAN-10
REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K093065.pdf

DEVICE: NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
NOVA BIOMEDICAL CORP. 510(k) NO: K091547(TRADITIONAL)
ATTN: PAUL MACDONALD PHONE NO : 781 894 0800
200 PROSPECT ST. SE DECISION MADE: 15-JAN-10
WALTHAM MA 02454 9141 510(k) SUMMARY AVAILABLE FROM FDA

http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091547.pdf
http://www.novacares.com/


DEVICE: EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
VISGENEER, INC. 510(k) NO: K091765(TRADITIONAL)
ATTN: EVONNE CHEN PHONE NO : 886 351 60111
3F-2, NO. 83, SEC. 2 GONGDAO 5TH RSE DECISION MADE: 19-JAN-10
HSINCHU CITY TW 30070 510(k) SUMMARY AVAILABLE FROM FDA